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overview
Key Learning Objectives
- Understand the different levels of requirements in CMC during development and post-approval phase
- Get an overview of the structure of the CTD Module 3 and Quality Overall Summary (QOS)
- Understand the essential requirements for a drug substance and how to submit them
- Learn how to write the CTD sections on manufacturing and excipients
- Control on the finished product: learn how to set appropriate specifications and write the section
- Understand the requirements for packaging materials
- Get an overview of stability requirements
About the Course
Preparing the registration dossier for the Marketing Authorisation application is a critical milestone of drug development. This course focuses on key regulatory requirements for the content and structure of the quality module of the Common Technical Document (CTD Module 3).
It provides knowledge on the scientific data that are required on the quality of the drug product and helps you understand the expectations of regulatory authorities worldwide in terms of content and level of details
Who Will Benefit
Any person involved in the preparation of the CTD Module 3, but also people from pharmaceutical development and/or production. For example:
- Regulatory Affairs
- Regulatory CMC
- Quality Assurance specialists
- Product scientists
- R&D pharmaceutical project managers
- Analytical and stability laboratory managers (from R&D to GMP)
- Production technical experts
pricing
Testimonials
“The course trainer was friendly and clearly very knowledgeable. I found the flexibility of the course and the structure very useful to fit around my schedule.”
Regulatory Affairs Specialist, Liqvor CJSC
Benefits of Learning Online
Informa Corporate Learning’s online courses are new digital, interactive and engaging educational experience designed to maximise learning for professionals with busy schedules and/or small training budgets.
Our online courses are perfect opportunity for busy professionals as they require just 2 hours per week of your time and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis, so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Agenda
Module 1: CMC in the Drug Development Programme
- What is CMC?
- Introduction to drug development.
- Considerations for CMC Data Requirements at different stages of drug development.
- Other considerations impacting CMC and Drug Development.
Module 2: CTD Module 3 & Quality Overall Summary
- Module 3 structure & Quality overall summary (QOS).
- Purpose and Content of Module 3 and QOS
- QOS Strategy
- Future Perspective
Module 3: Preparing the Drug Substance section of the application
- Analysing the needs for the section
- How to submit information – Drug Master Files, Certificates of Suitability, other methods
- Detailed information requirements for the section
Module 4: Essential information from API suppliers
- Identify essential data requirement
- Understand the essential requirements from API suppliers / manufacturing section
- Impact on finished products
Module 5: Meeting manufacturing and inspection requirements
- Regulatory compliance and manufacturing issues in relation to the application
- Clarifying manufacturing licence criteria
- Preparing for pre-approval inspection
- Examining the relation between GMP and CTD Module 3
Module 6: Writing the section on manufacture of the drug product and process validation
- Examining the content of the section: How much information to provide
- Defining the difference between process development and validation
- Post-approval commitments
- Writing the sections on excipients
- Examining the content of the section
Module 7: Writing the sections on control of the finished product
- Examining the content of the section
- Control of the drug product
Module 8: Module 7 Specifications
- Identify and understand the writing of specifications Dossier Requirements.
- Adjusting specifications during development.
- Justification of specifications.
Module 9: Stability Section
- Examine the content of the section
- Evaluation of stability data and the impact on shelf-life
- QbD and Stability
Module 10: Pharmaceutical Packaging
- Regulatory requirements for pharmaceutical packaging
- How to reflect requirements in the dossier
- Quality and suitability of packaging
- Packaging specifications
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.